Incyte has announced positive topline results from a late-stage study of its JAK inhibitor cream Opzelura (ruxolitinib) in children aged two to 11 years with atopic dermatitis, the most common type of eczema.
An estimated two to three million children in the US, aged two to 11 years, are affected by atopic dermatitis, an inflammatory skin disease that causes itchy, red, swollen, and cracked skin.
The phase 3 TRuE-AD3 trial met its primary endpoint, with significantly more Opzelura-treated patients achieving clear or almost clear skin with at least a two-point improvement on the Investigators’ Global Assessment Treatment Success score at week eight compared to those receiving non-medicated cream.
The long-term safety portion of the study will continue as planned, the company said, with patients who successfully completed an efficacy assessment at week eight offered participation in the 44-week long-term safety treatment extension period.
Jim Lee, group vice president, inflammation and autoimmunity at Incyte, said: “Atopic dermatitis is a chronic, immune-mediated skin condition that affects about 13% of all children in the US. It can cause disruptive symptoms like redness, dry skin, and intense itch, which can detrimentally impact quality of life and be difficult to manage for both the child and their caregivers.”
Lee added: “This new positive data reinforces the potential of [Opzelura] cream to offer children a much-needed effective, non-steroidal topical therapy. We look forward to discussing these data with regulatory agencies to determine next steps.”
The positive readout comes just a few months after the European Commission (EC) approved Opzelura to treat adults and adolescent patients aged 12 years and older with non-segmental vitiligo with facial involvement.
The EC’s decision, which followed a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, made the JAK inhibitor the first and only approved treatment in the EU to target re-pigmentation in this patient population.
The cream is also approved in the US to treat patients aged 12 years and older with non-segmental vitiligo and for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.